Posters - NCDEU: An Annual Meeting Sponsored by ASCP

Thursday, May 31, 2012
7:00 am - 8:30 am NCDEU Steering Committee Meeting
Kaibab
7:30 am – 8:30 am New Investigator Awardee Roundtable
(Invitation Only)
Aztec
7:30 am – 9:30 am Continental Breakfast
Frank Lloyd Wright Ballroom Foyer
8:30 am – 10:00 am Regulatory Plenary - New FDA and EMA Initiatives
in Depression and Schizophrenia
Frank Lloyd Wright Salon E-F
Co-Chairs: Thomas Laughren, M.D., Food & Drug Administration
Karl Broich, M.D., Federal Institute for Drugs and Medical
Devices (BfArM, Germany)
8:30 am – 8:50 am Clinical Trials for Major Depression (MDD): Current
Views from EU
Karl Broich, M.D., Federal Institute for Drugs and
Medical Devices (BfArM, Germany)
MDD is one of the most common psychiatric
disorders, which is the fourth leading cause of global
disease burden. Despite the many treatment options
currently approved for MDD, a relevant proportion of
patients up to one third does not adequately respond
to treatment, even if there is good compliance and
the treatment has been taken long enough with an
adequate dosage. So there is a clear unmet medical
need for patients, in whom even “state of the art”-
antidepressant therapy fails to elicit a sufficient
treatment response. Following a public consultation
period the revision of the “Note for guidance on
Clinical Investigation of Medicinal Products in the
Treatment of Depression” gets now finalized. The
regulatory requirements for development programs
of antidepressant medicinal products are reviewed,
special emphasis is given to issues regarding studied
patient population (e.g. partial response, treatment
resistance) and study designs (short-term and
maintenance, active comparator).
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